Cardiology / GeneticsHereditary ATTR Amyloidosis

CardioNavigATTR (36 genes)

Covers the TTR gene plus 35 other cardiomyopathy genes to identify variant-associated risk for hereditary transthyretin amyloidosis (hATTR) and related cardiac conditions

Accessed through the NavigATTR Sponsored Testing ProgramSponsored by AstraZeneca, Ionis PharmaceuticalsPerformed by Prevention Genetics

Designed to help patients understand the purpose of testing and what to expect.

For patients

What this test and program do

When doctors suspect that a heart condition might run in your family, genetic testing can provide important answers. The CardioNavigATTR program, part of the NavigATTR initiative and sponsored by AstraZeneca and Ionis Pharmaceuticals, gives eligible adults in the United States access to a comprehensive 36-gene panel that looks at hereditary causes of cardiomyopathy, including the TTR gene linked to hereditary ATTR (hATTR) amyloidosis. The test is provided at absolutely no cost to you, and the program also includes genetic counseling support to help you understand your results.

Who this may help

Could this be right for you or your family?

  • To qualify, all of the following must be met:
    • The patient is 18 or older
    • The patient lives in the United States
    • The patient meets at least one of the following:
      • At least one of the following:
        • A family history of hereditary ATTR (hATTR) amyloidosis
        • A positive cardiac nuclear scan (99mTc-PYP/DPD/HMDP uptake on bone scintigraphy) with no abnormal (monoclonal) protein in the blood or urine
        • A biopsy positive for amyloidosis
      • At least one symptom from two separate categories below:
        • Autonomic dysfunction
          • Bladder dysfunction
          • Early satiety
          • Erectile dysfunction
          • Orthostatic hypotension
        • Bilateral carpal tunnel syndrome
        • Gastrointestinal
          • Nausea and vomiting
          • Alternating bouts of diarrhea/constipation
        • Heart disease
          • Arrhythmias
          • Heart failure or cardiomyopathy
          • Edema
          • Fatigue
          • Shortness of breath
        • Lumbar spinal stenosis
        • Motor dysfunction
          • Difficulty walking
          • Impaired balance
          • Muscle weakness
        • Neurological disease
          • Numbness and tingling in feet and/or hands
          • Pain in extremities
          • Sensitivity to pain and temperature
        • Renal issues
          • Proteinuria
          • Renal insufficiency/failure
    • Testing is ordered by a qualified healthcare provider

What to expect

How the process works

  1. 1

    Confirm Eligibility

    Talk with your health care provider to determine whether you meet the program’s eligibility criteria and whether this test is appropriate for you.

  2. 2

    Test Ordering

    Your provider will order the test using the online portal or the program’s test requisition form.

  3. 3

    Provide a Specimen

    Your provider will collect the specimen and label it with at least two identifiers. Specimens are accepted Monday–Saturday, with holiday schedules posted in advance.

  4. 4

    Receive Your Results

    PreventionGenetics processes the test and sends results to your provider in about two weeks. Your provider will review the findings, and no-cost genetic counseling is available.

Cost & coverage

Understanding potential costs

If you qualify for this program, the sponsor works with the laboratory to help make testing more affordable. Many patients pay little or no out-of-pocket cost. Your exact cost will depend on your insurance coverage and the specific criteria of the program, and the lab can explain what to expect before your sample is processed.

Quality & privacy

How your sample and information are handled

Testing is performed by Prevention Genetics, a CLIA-certified laboratory (CLIA 52D2065132) and College of American Pathologists (CAP) certified laboratory (CAP 7185561). Your sample is processed using validated methods and quality controls to support reliable genetic results.

Your health information is handled under privacy and security practices that are intended to align with applicable regulations. For program- and lab-specific details, review the privacy information provided by the laboratory and sponsor.

FAQ

Common questions about this program

What is the CardioNavigATTR genetic testing program for hereditary ATTR amyloidosis?

CardioNavigATTR is a sponsored genetic testing program designed for adults who may be at risk for hereditary ATTR amyloidosis or other inherited forms of cardiomyopathy. The program uses a 36-gene panel that includes the TTR gene to help your doctor determine whether a genetic cause is behind your heart condition. It is performed by Prevention Genetics, and results are typically ready in 2 to 3 weeks.

Is the CardioNavigATTR genetic test for hereditary ATTR amyloidosis really free?

Yes, the CardioNavigATTR test is provided at no cost to you. The program is fully funded by AstraZeneca and Ionis Pharmaceuticals, so there is no charge, no copay, and no deductible for eligible patients. You will not receive a bill for the genetic testing or the genetic counseling that comes with the program.

What kind of sample is needed for the CardioNavigATTR hereditary ATTR amyloidosis test?

The CardioNavigATTR program accepts a few different sample types, including a simple blood draw, a saliva sample, or a buccal swab (a gentle cheek swab). Your doctor's office will order a free collection kit and let you know which option works best for your situation. The process is straightforward and can often be done right at your provider's office.

How long does it take to get results from the CardioNavigATTR hereditary cardiomyopathy panel?

Results from the CardioNavigATTR test are typically available within 2 to 3 weeks after your sample arrives at the laboratory. Your ordering healthcare provider will receive the results and review them with you. The program also offers genetic counseling to help you understand what the findings mean for you and your family.

Does the CardioNavigATTR program include genetic counseling for hereditary ATTR amyloidosis results?

Yes, the CardioNavigATTR program includes genetic counseling support as part of the no-cost program. Genetic counselors can help explain your test results, discuss what they may mean for your health, and talk about whether family members might also benefit from testing. This support is included at no additional charge.

Who qualifies for NavigATTR Hereditary ATTR Amyloidosis genetic testing?

Patients may qualify for NavigATTR if they meet the program's eligibility criteria:

  • Must be a U.S. resident and 18 years of age or older.
  • May qualify with a family history of hereditary transthyretin amyloidosis (hATTR), a positive PYP scan, or a biopsy consistent with amyloidosis.
  • Patients with two or more red-flag symptoms suggestive of hATTR may also qualify.
  • Testing must be ordered by a licensed health care professional.

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